Morbid ObesityNCT01285791
Sonographic Evaluation of Visceral Fat After Bariatric Surgery
An observational study of Morbid Obesity, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Excess visceral fat is a key factor in the development of metabolic syndrome associated with obesity. After bariatric surgery, patients experience weight loss accompanied by a decrease in the amount of total body fat. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Morbid Obesity
- How many people
- 39 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Morbid obese patients admitted electively to our surgery ward after receiving detailed explanation about each type of surgery and after independently choosing to undergo either a laparoscopic adjustable gastric banding, a sleeve gastrectomy or a gatsric bypass will be offered to participate in the study. The patients must meet criteria for being morbid obese as defined as a body mass index greater than 40 kg/meter*meter or a body mass index greater than 35 with relevant comorbidities. The patients must meet other inclusion and exclusion criteria as defined below. The patients will be offered to participate in the study regardless of their gender or race.
Who may be able to join
- age above 18 years and below 70 years
- patients considered to suffer from morbid obesity as defined as a body mass index above 40 kg/meter*meter or above 35 kg/meter*meter with comorbidities relevant to obesity such as : diabetes, hypertension, arthralgia, obstructive sleep apnea and hyperlipidemia and eligible for surgery
- patients that electively and independently chose to undergo a bariatric surgery in our surgery ward.
- patients expressing their desire to participate in the study and after signing informed consent.
- patients that underwent a lecture about the pros and cons of the different types of bariatric surgery performed in our surgery ward:laparoscopic adjustable gastric banding, a sleeve gastrectomy or a gastric bypass and chose independently the type of surgery they want to undergo.
- patients that tried to lose weight in conventional ways such as physical activity and diets with no success.
Who cannot join
- patients under the age of 18 or above the age 70.
- patients unable to read, understand, comprehend and sign the informed consent form.
- patients not meeting the criteria for the definition morbid obesity as defined as a body mass index above 40 kg/meter*meter or above 35 kg/meter*meter with comorbidities relevant to obesity such as : diabetes, hypertension, arthralgia, obstructive sleep apnea and hyperlipidemia.
- pregnant patients.
- patients addicted to alcohol or other recreational drugs.
- patients suffering from a malignant comorbidity.
- patients suffering for a morbid obesity state because of a endocrine problem such as hypothyroidism or cushing disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sonographic Evaluation of Visceral and Subcutaneous Fat in Morbidly Obese Patients Before and After 3 Different Types of Bariatric Surgery.
Excess visceral fat is a key factor in the development of metabolic syndrome associated with obesity. After bariatric surgery, patients experience weight loss accompanied by a decrease in the amount of total body fat. It is unclear how the different surgical procedures vary in their effect on the visceral and subcutaneous fat change. Ultrasonography (US) is an effective, efficient method in assessing this metabolically active layer of fat even when compared with gold standard techniques such as computed tomography and magnetic resonance imaging. Only a few studies managed to show the actual decrease in the visceral fat layer after these kinds of surgeries. The aim is to compare by ultrasound evaluation the extent of fat layers reduction after laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG) and laparoscopic roux-en-y gastric bypass (LRYGB). The hypothesis is that the sleeve gastrectomy and gastric bypass being not only a restrictive procedure but also a malabsorptive procedure will have the best results in decreasing the amount of visceral fat.
Read the detailed description
excess visceral fat is a key factor in the development of metabolic syndrome associated with obesity. After bariatric surgery, patients experience weight loss accompanied by a decrease in the amount of total body fat. It is unclear how the different surgical procedures vary in their effect in reducing the amount of the visceral fat layer . Ultrasonography (US) is an effective, efficient method in assessing this metabolically active layer of fat even when compared with gold standard techniques such as computed tomography and magnetic resonance imaging. Only a few studies managed to show the actual decrease in the visceral fat layer after these kinds of bariatric surgeries. The aim is to compare by ultrasound evaluation the extent of fat layers reduction after laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG) and laparoscopic roux-en-y gastric bypass (LRYGB).
Visceral fat (VF) will be defined as the depth, in centimeters, from the rectus abdominis muscle to the aorta; and subcutaneous fat (SCF) defined as the depth, in centimeters, from the skin to the rectus abdominis muscle. Results will be compared with anthropometric measures as weight and waist circumference as well as laboratory results to try and find correlation between sonographic improvement and anthropometric and laboratory improvement.
The hypothesis is that the sleeve gastrectomy and gastric bypass being not only a restrictive procedure but also a malabsorptive procedure will have the best results in decreasing the amount of visceral fat.
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, intra-abdominal visceral fat, gastric bypass, sleeve gastrectomy, gastric banding, visceral fat
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing laparoscopic adjustable gastric banding | morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased. | |
| patients undergoing laparoscopic sleeve gastrectomy | morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased | |
| patients undergoing laparoscopic gastric bypass | morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery.
morbid obese patients undergoing a type of bariatric surgery either a laparoscopic gastric banding, a laparoscopic sleeve astrectomy or a laparoscopic gastric bypass, in our department will be evaluated by ultrasound 1 day before surgery and one year after surgery to determine the amount of visceral fat layer-by centimeters- that was decreased .
Measured: 18 months
Secondary outcomes (1)
Change in Glucose and Triglyceride Blood Level
finding correlation between sonographic outcome using ultrasound, as measured by the decrease in the level of visceral fat-by centimeters, weight loss and blood levels of triglycerides and glucose.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ido Mizrahi, Hadassah Medical Organization
- Investigators
- Ido Mizrahi, M.D, Principal investigator, Ministry of Health, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285791
- Sponsor's protocol ID
- obesity17-HMO-CTIL
- Status last verified
- Feb 2016
- First submitted
- 10 Jan 2011
- Last updated
- 16 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: not planning on sharing data
Publications
Del Genio F, Del Genio G, De Sio I, Marra M, Alfonsi L, Finelli C, Contaldo F, Pasanisi F. Noninvasive evaluation of abdominal fat and liver changes following progressive weight loss in severely obese patients treated with laparoscopic gastric bypass. Obes Surg. 2009 Dec;19(12):1664-71. doi: 10.1007/s11695-009-9891-x.
PubMed 19526270
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation of Visceral and Subcutaneous Fat in Morbidly Obese Patients Before and After 3 Different Types of Bariatric Surgery.
- ClinicalTrials.gov ID
- NCT01285791
- Acronym / sponsor ID
- obesity17-HMO-CTIL
- Conditions
- Morbid Obesity
- Keywords
- morbid obesity, intra-abdominal visceral fat, gastric bypass, sleeve gastrectomy, gastric banding, visceral fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Posted 16 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Excess visceral fat is a key factor in the development of metabolic syndrome associated with obesity. After bariatric surgery, patients experience weight loss accompanied by a decrease in the amount of total body fat. It is unclear how the different surgical procedures vary in their effect on the visceral and subcutaneous fat change. Ultrasonography (US) is an effective, efficient method in assessing this metabolically active layer of fat even when compared with gold standard techniques such as computed tomography and magnetic resonance imaging. Only a few studies managed to show the actual decrease in the visceral fat layer after these kinds of surgeries. The aim is to compare by ultrasound evaluation the extent of fat layers reduction after laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG) and laparoscopic roux-en-y gastric bypass (LRYGB). The hypothesis is that the sleeve gastrectomy and gastric bypass being not only a restrictive procedure but also a malabsorptive procedure will have the best results in decreasing the amount of visceral fat.
Detailed description
excess visceral fat is a key factor in the development of metabolic syndrome associated with obesity. After bariatric surgery, patients experience weight loss accompanied by a decrease in the amount of total body fat. It is unclear how the different surgical procedures vary in their effect in reducing the amount of the visceral fat layer . Ultrasonography (US) is an effective, efficient method in assessing this metabolically active layer of fat even when compared with gold standard techniques such as computed tomography and magnetic resonance imaging. Only a few studies managed to show the actual decrease in the visceral fat layer after these kinds of bariatric surgeries. The aim is to compare by ultrasound evaluation the extent of fat layers reduction after laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG) and laparoscopic roux-en-y gastric bypass (LRYGB).
Visceral fat (VF) will be defined as the depth, in centimeters, from the rectus abdominis muscle to the aorta; and subcutaneous fat (SCF) defined as the depth, in centimeters, from the skin to the rectus abdominis muscle. Results will be compared with anthropometric measures as weight and waist circumference as well as laboratory results to try and find correlation between sonographic improvement and anthropometric and laboratory improvement.
The hypothesis is that the sleeve gastrectomy and gastric bypass being not only a restrictive procedure but also a malabsorptive procedure will have the best results in decreasing the amount of visceral fat.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients undergoing laparoscopic adjustable gastric banding | – | –morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased. |
| patients undergoing laparoscopic sleeve gastrectomy | – | –morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased |
| patients undergoing laparoscopic gastric bypass | – | –morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Morbid obese patients admitted electively to our surgery ward after receiving detailed explanation about each type of surgery and after independently choosing to undergo either a laparoscopic adjustable gastric banding, a sleeve gastrectomy or a gatsric bypass will be offered to participate in the study. The patients must meet criteria for being morbid obese as defined as a body mass index greater than 40 kg/meter*meter or a body mass index greater than 35 with relevant comorbidities. The patients must meet other inclusion and exclusion criteria as defined below. The patients will be offered to participate in the study regardless of their gender or race.
Key inclusion criteria (6 listed)
- age above 18 years and below 70 years
- patients considered to suffer from morbid obesity as defined as a body mass index above 40 kg/meter*meter or above 35 kg/meter*meter with comorbidities relevant to obesity such as : diabetes, hypertension, arthralgia, obstructive sleep apnea and hyperlipidemia and eligible for surgery
- patients that electively and independently chose to undergo a bariatric surgery in our surgery ward.
- patients expressing their desire to participate in the study and after signing informed consent.
- patients that underwent a lecture about the pros and cons of the different types of bariatric surgery performed in our surgery ward:laparoscopic adjustable gastric banding, a sleeve gastrectomy or a gastric bypass and chose independently the type of surgery they want to undergo.
Key exclusion criteria (7 listed)
- patients under the age of 18 or above the age 70.
- patients unable to read, understand, comprehend and sign the informed consent form.
- patients not meeting the criteria for the definition morbid obesity as defined as a body mass index above 40 kg/meter*meter or above 35 kg/meter*meter with comorbidities relevant to obesity such as : diabetes, hypertension, arthralgia, obstructive sleep apnea and hyperlipidemia.
- pregnant patients.
- patients addicted to alcohol or other recreational drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery.
Time frame: 18 months
morbid obese patients undergoing a type of bariatric surgery either a laparoscopic gastric banding, a laparoscopic sleeve astrectomy or a laparoscopic gastric bypass, in our department will be evaluated by ultrasound 1 day before surgery and one year after surgery to determine the amount of visceral fat layer-by centimeters- that was decreased .
1 secondary outcome
Change in Glucose and Triglyceride Blood Level
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19526270Del Genio F, Del Genio G, De Sio I, Marra M, Alfonsi L, Finelli C, Contaldo F, Pasanisi F. Noninvasive evaluation of abdominal fat and liver changes following progressive weight loss in severely obese patients treated with laparoscopic gastric bypass. Obes Surg. 2009 Dec;19(12):1664-71. doi: 10.1007/s11695-009-9891-x.
- Individual participant dataSharing planned: No. not planning on sharing data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ido Mizrahi, M.D principal investigator
Ministry of Health, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in the Visceral Fat Layer Measured by Ultrasound a Day Before and a Year After Surgery. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01285791, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.